U.S. PHARMACOPEIA

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Gentamicin Sulfate Ophthalmic Solution
» Gentamicin Sulfate Ophthalmic Solution is a sterile, buffered solution of Gentamicin Sulfate with preservatives. It contains the equivalent of not less than 90.0 percent and not more than 135.0 percent of the labeled amount of gentamicin.
Packaging and storage— Preserve in tight containers, and avoid exposure to excessive heat.
pH 791: between 6.5 and 7.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements of the Identification test under Gentamicin Injection and meets the requirements under Sterility Tests 71, when tested as directed in the section Membrane Filtration in Test for Sterility of the Product To Be Examined.
Assay— Proceed with Ophthalmic Solution as directed in the Assay under Gentamicin Injection.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 995
Phone Number : 1-301-816-8223